Prescription drug · NDA AUTHORIZED GENERIC
alogliptin and metformin hydrochloride NDC 50090-5993
Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5993-0 | 50090599300 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5993-0)Marketed from Jun 10, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- alogliptin and metformin hydrochloride
- Generic name (nonproprietary)
- alogliptin and metformin hydrochloride
- Active ingredients
- Alogliptin benzoate — 12.5 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 203414
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-5993_58968f11-76a2-4e8d-8414-dc636614dedbSPL ID 58968f11-76a2-4e8d-8414-dc636614dedbSPL set ID 9112d6b9-4771-4194-886d-7db887470bccRxCUI 1368385UNII EEN99869SC, 786Z46389E
- Pharmacologic class
- Biguanide; Dipeptidyl Peptidase 4 Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090599300followed by a unit qualifier and the quantityPackage 50090-5993-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Alogliptin and metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin and metformin HCl tablets are a combination of alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor and metformin, a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Should not be used in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Alogliptin and metformin HCl tablets should not be used in patients with type 1 diabetes mellitus.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203414
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Kazanoalogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-335 |
| Kazanoalogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-337 |
| alogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-169 |
| alogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-211 |